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U.S. Department of Health and Human Services

Class 2 Device Recall OneTray Sealed Sterilization Container

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 Class 2 Device Recall OneTray Sealed Sterilization Containersee related information
Date Initiated by FirmFebruary 03, 2014
Date PostedOctober 22, 2015
Recall Status1 Terminated 3 on February 04, 2016
Recall NumberZ-0153-2016
Recall Event ID 72011
510(K)NumberK052567 
Product Classification Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
ProductOneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
Code Information M2104 Lot # 044305, 044379, 044380 & 044418.  M2408 Lot # 044296, 022304, 044381, 044420, 044421 & 044422.
Recalling Firm/
Manufacturer		 Innovative Sterlization Technologies LLC
7625 Paragon Rd Ste A
Dayton OH 45459-4063
For Additional Information ContactMr. David S. Billman
937-619-0138
Manufacturer Reason
for Recall		The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at 270 degrees F instead of Steam Gravity 17 - 34 minutes at 270 degrees F.
FDA Determined
Cause 2		Process control
ActionThe firm sent an Urgent Medical Device Recall letter dated September 14, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to fill out the attached response SASE mailer and return to or fax to the address/number identified below: Innovative Sterilization Technologies, LLC, 7625 Paragon Road, Suite A Dayton, OH 45459, 937-286-3571 (C), 937-630-4346 (F), 937-619-0138 x 202 (Office), dbillman@ISTSterilization.com
Quantity in CommerceM2104 - 25 units; M2408 - 84 units
DistributionUS Nationwide Distribution in the states of IL, IN, LA, OH, PA, TX & WV.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KCT
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